2nd UPDATE: Abbott, Medtronic: Stents Perform Well At 3 Years
21 Septembre 2009 - 9:37PM
Dow Jones News
Stent heart devices from Abbott Laboratories (ABT) and Medtronic
Inc. (MDT) outperformed an older device from Boston Scientific
Corp. (BSX) in three-year data from two studies by better helping
patients avoid serious events, Abbott and Medtronic said
Monday.
They released fresh study details during the Transcatheter
Cardiovascular Therapeutics conference in San Francisco. The data
came from separate, company-funded studies that Abbott and
Medtronic used to win approval for their drug-coated stents in the
U.S. last year. The scaffolds for heart arteries use medication to
fight renarrowing and make up a roughly $4 billion global
market.
Abbott's Xience stent leads the domestic market behind solid
study data, and Medtronic has been working to improve modest sales
for its Endeavor stent by highlighting the device's long-term
safety profile.
Boston Scientific is a major market player through both
home-grown stents and a version of the Abbott stent, called Promus,
it sells under a profit-sharing deal.
In both studies released Monday, Abbott and Medtronic devices
were measured against the Taxus Express stent from Boston
Scientific that formerly led in the U.S. but has since been
replaced by a newer version called Taxus Liberte. Boston Scientific
noted this fact. Abbott and Medtronic, meantime, have argued that
their studies remain relevant because of similarities between the
newer and older Boston Scientific devices.
Donald S. Baim, chief medical and scientific officer at Boston
Scientific, said in a statement the company was "very pleased" with
how Taxus Express performed in the Abbott trial's match-up.
Shares of all involved companies were recently higher, with
Abbott up 55 cents, or 1.2%, to $46.52. Medtronic traded up 10
cents to $37.56, while Boston Scientific traded 17 cents higher to
$11.14.
The Spirit III study for Abbott's Xience stent has previously
shown Xience outperforming the Boston Scientific device on certain
fronts, including a composite measurement of serious events
including death and heart attacks.
In the three-year data from the 1,002-patient study, Abbott's
stent had a 9.1% rate of so-called major adverse cardiac events,
compared with a 15.7% rate for Taxus Express, Abbott said. In
addition to cardiac death and heart attacks, that composite
measurement includes retreatment of the same area in the affected
artery.
On another combined measure of events called target lesion
failure, the rate was 8.3% with Xience and 14.4% with the Boston
Scientific stent, Abbott said.
The company also noted that Xience had no additional cases of
late-developing, stent-related clots in the study between years two
and three.
Diabetic patients, who are a large segment of the stent market
and can be tricky to treat, have become a focal point between the
stent makers. Both Abbott and Boston Scientific highlighted how
their stents performed among diabetics in the Spirit III study.
Boston Scientific's Baim noted that diabetics with Taxus Express
had a lower rate of retreatment in the previously treated area than
non-diabetics with the device, and that the stents made by Abbott
and Boston Scientific performed similarly on this front.
Abbott cited market-share estimates for July from an outside
firm that show Xience and Promus holding more than half the U.S.
market combined. Taxus Liberte is next at 20%, followed by a
Johnson & Johnson (JNJ) stent and Medtronic's Endeavor.
Endeavor's share has been squeezed by the popularity of Xience
and Promus, but also the perception created by some earlier study
data that Endeavor isn't a strong performer when it comes to
avoiding renarrowing that can lead to repeat procedures.
The fresh evidence from Medtronic's 1,548-patient Endeavor IV
study doesn't show a difference between Endeavor and Taxus Express
at three years on measures of retreatment. But it does show fewer
late-developing clots for Endeavor between years one and three, and
this fuels a finding of fewer heart attacks with the Medtronic
stent at three years, the company said.
Medtronic also noted better performance for Endeavor on a
combined measure of heart attacks and death due to heart
events.
Avoiding rare but potentially deadly clots that develop after a
year became a serious concern in the coated-stent market after
evidence arose three years ago about the dangers of such
developments. While clotting worries have since eased, the need to
keep coated-stent patients on long courses of anti-clotting drugs
has kept doctors from using those devices in many cases.
In the Endeavor IV study, Endeavor had more cases of clots
through 360 days than Boston Scientific's stent. But there was one
case among Endeavor patients between 360 days and 1,080 days, and
11 cases among Taxus Express patients in that span.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com